Systems and methods for planning medical procedures

ABSTRACT

Computer systems and computer-implemented analysis methods may be used for assistance in planning and/or performing a medical procedure, such as percutaneous nephrolithotomy or percutaneous nephrolithotripsy. The method may include receiving one or more radiographic images of an anatomical structure of a patient, generating a display of the radiographic image(s), generating at least one request for user input to identify features of the anatomical structure, receiving user input identifying the features of the anatomical structure, identifying at least one access plan based on the received user input, and generating a display of the identified access plan(s) associated with the radiographic image(s). The method may include generating a patient template that indicates an insertion site according to the identified access plan(s).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalApplication No. 62/275,466, filed on Jan. 6, 2016, which is incorporatedby reference herein in its entirety.

TECHNICAL FIELD

Various aspects of the present disclosure relate generally to systemsand methods useful in planning and/or performing medical procedures.

BACKGROUND

Substantial progress has been made towards increasing the effectivenessof medical treatment while reducing trauma and risks to the patient.Many procedures that once required open surgery now may be done withless invasive techniques that limit the size of incision, thus providingfor less recovery time and risks of infection for the patient. Certainprocedures requiring biopsy, electro-stimulation, tissue ablation, orremoval of native or foreign bodies may be performed throughminimally-invasive surgery.

In the field of urology, for example, renal calculi or kidney stones canaccumulate in the urinary tract and become lodged in the kidney. Kidneystones are deposits of materials from the urine, typically minerals andacid salts. While smaller stones may pass from the body naturally,larger stones can require surgical intervention for removal. While opensurgery was once the standard treatment for the removal of stones, otherless invasive techniques, such as ureteroscopy and percutaneousnephrolithotomy/nephrolithotripsy (PCNL), have emerged as safer,effective alternatives. Yet, procedures such as PCNL still carry risks.

Minimally-invasive procedures like PCNL offer benefits in patientrecovery, but afford the physician only a limited view of the treatmentsite. As a result, it may be difficult to gain sufficient access to atargeted site without causing collateral injury to the patient. Withoutsufficient knowledge of the patient's anatomy, a physician may needseveral attempts to properly position and orient the instruments toremove the stone. If the stone is larger or more difficult to grasp thanexpected for the first route of access, a secondary route of access maybe necessary. Repeated attempts at access increase the risk ofcollateral injury to blood vessels, surrounding tissue, and neighboringorgans, and can increase the likelihood of hemorrhage, infection, andfluid leakage/sepsis.

Medical personnel who do not routinely perform PCNL procedures may beespecially anxious at the possibility of injury due to impropertriangulation to the stone. While patient images like computertomography (CT) scans may be available for reference beforehand, theyoften are obtained weeks or months before the PCNL procedure. The stonemay have grown in size and/or changed position during the interim, thusadding further uncertainty to successfully removing the stone withminimal harm to the patient.

SUMMARY

The present disclosure includes a method for determining apatient-specific surgical access plan for a medical procedure using atleast one computer system, the method comprising receiving over anelectronic network, at the at least one computer system, one or moreradiographic images of an anatomical structure of a patient; generatinga display of the one or more radiographic images; generating at leastone request for user input to identify features of the anatomicalstructure in the one or more radiographic images; receiving a first userinput identifying the features of the anatomical structure; identifying,by the at least one computer system, at least one access plan forperforming the medical procedure based on the received user input; andgenerating a display of the identified at least one access planassociated with the one or more radiographic images. In some examples,the medical procedure may be percutaneous nephrolithotomy orpercutaneous nephrolithotripsy, and the anatomical structure may be akidney.

According to some aspects, the one or more radiographic images mayinclude images obtained by computer tomography. The display may include,for example, a three-dimensional representation of the anatomicalstructure, which may be reconstructed from computer tomography and/orother imaging methods. The radiographic image(s) need not be obtained bycomputer tomography, or may include additional images obtained byimaging techniques other than computer tomography.

The method may further comprise one or more additional steps. Forexample, the method may further comprise modifying the one or moreradiographic images based on the first user input. Modifying the one ormore radiographic images may include, for example, comparing the one ormore radiographic images to reference patient data for the medicalprocedure. Additionally or alternatively, the method may comprisemanually and/or automatically identifying one or more features of theanatomical structure in the one or more radiographic images beforegenerating the at least one request for user input.

In some examples, generating the at least one request for user inputincludes asking a user to identify and/or confirm a location of a kidneystone in the one or more radiographic images. Further, for example, themethod may include calculating, by the at least one computer system, atleast one characteristic of the kidney stone based on the radiographicimage(s). According to some aspects, the characteristic(s) may be chosenfrom stone burden, stone density, skin to kidney capsule distance, skinto kidney stone distance, or a combination thereof. Othercharacteristics of the kidney stone may be calculated, identified, orotherwise determined. Identifying the at least one access plan mayinclude calculating a needle trajectory based on the calculated at leastone characteristics of the kidney stone.

According to some aspects, the method may comprise generating a patienttemplate that indicates one or more sites (e.g., insertion site(s) forinserting a needle) according to the identified access plan(s). Theaccess plan(s) may include a location and a depth for inserting a needleat the insertion site, e.g., such that the access plan(s) identify asuitable position for the needle to access the patient's anatomy forperforming the medical procedure. Generating the patient template mayinclude, for example, printing one or more markings identifying theinsertion site to a sheet or other material suitable for transfer to apatient prior to the medical procedure. For example, generating thepatient template may include printing at least a first markingidentifying the insertion site according to the access plan and a secondmarking providing a reference relative to one or more anatomicalfeatures of the patient. Additionally or alternatively, the at least oneaccess plan may include information on a trajectory of the needle forinsertion at the insertion site.

According to some aspects of the present disclosure, the method maycomprise performing the medical procedure by inserting a needle at aninsertion site according to the at least one access plan. The insertionsite may be identified by a light source, e.g., a laser light source orother light source of an imaging device, which may be directed towardsthe skin of the patient. The light source may be in communication withthe electronic network.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various exemplary embodiments andtogether with the description, serve to explain the principles of thedisclosed embodiments.

FIG. 1 illustrates anatomical features of a kidney.

FIG. 2 is a schematic diagram of a system and environment for processingand displaying patient data, in accordance with aspects of the presentdisclosure.

FIG. 3 shows an exemplary imaging device, in accordance with aspects ofthe present disclosure.

FIG. 4 is a flow diagram of an exemplary method for processing anddisplaying patient data, in accordance with aspects of the presentdisclosure.

FIGS. 5 and 6 show exemplary screenshots of a graphical user interfaces,in accordance with aspects of the present disclosure.

FIGS. 7A and 7B show an exemplary patient template, in accordance withaspects of the present disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure include systems and methods tofacilitate, and improve the efficacy and safety of minimally-invasivesurgeries. For example, aspects of the present disclosure may provide auser (e.g., a physician, medical technician, or other medical serviceprovider) with the ability to manipulate patient-specific data toanalyze and/or simulate different aspects of a medical procedure. Insome embodiments, for example, the present disclosure may be used inplanning and/or performing a PCNL procedure.

PCNL is a minimally-invasive procedure for removing stones from thekidney, and is generally used when other techniques such as ureteroscopyor extracorporeal shock wave lithotripsy are not suitable. For example,PCNL may be appropriate for larger-sized stones (e.g., stones largerthan about 2 cm in diameter) or stones that are disposed near thepelvis. FIG. 1 illustrates the location and structure of a kidney 100.The left and right kidneys 100, 101 are located toward the rear of theabdominal cavity, and connected to the circulatory system through theabdominal aorta 130 and the inferior vena cava 132. The renal capsule102 is tough fibrous tissue that houses the parenchyma 104, the innertissue of the kidney 100. A series of minor calyces 106 channel urineinto major calyces 108, leading into the renal pelvis 110, which becomesthe ureter 112. The renal artery 120 and renal vein 122 supply blood toblood vessels disposed throughout the parenchyma tissue 104.

In a typical PCNL procedure, a small incision (−0.5-1.5 cm in diameter)is made in the patient's back through the skin overlying the affectedkidney. A small needle is then inserted and advanced into the kidneyproximate the stone, and a guide wire is passed through the needle. Theneedle then is removed with the guide wire remaining in place, and anephroscope is inserted over the guide wire and positioned proximate thestone as the guide wire is withdrawn. The nephroscope typically includesa light source, an imaging device, and a working channel forsuction/irrigation or use of auxiliary instruments to capture and removethe stone. If the stone cannot be removed directly (nephrolithotomy), itmay be broken into smaller pieces or fragments (nephrolithotripsy),e.g., via ultrasound, laser, or electrohydraulic techniques, tofacilitate removal.

One of the more challenging aspects of PCNL is insertion and properplacement of the needle. Improper positioning could risk puncturing ablood vessel resulting in hemorrhage, cause damage to neighboring organsor tissues, or ultimately place the nephroscope in an incorrect positionto access the stone. A detailed understanding of the patient's anatomyand potential access routes may allow the physician to sufficientlyprepare for the procedure.

The systems and methods disclosed herein may facilitate collecting,retrieving, analyzing, and/or manipulating patient images and other datato facilitate a PCNL procedure. In some embodiments, the systems andmethods disclosed herein may enable a physician to identify, evaluate,and/or simulate different surgical access plans, e.g., pathways oraccess routes through a patient's anatomy, for retrieving the stone. Forexample, the physician may execute a computer application via anelectronic device to process images and/or retrieve processed images foridentifying the presence of a stone and determining the dimensions,density, composition, location, orientation, and/or position of thestone relative to the kidney and surrounding anatomy. Further, in someembodiments, the application may identify and/or simulate one or moreaccess plans associated with the patient images. For example, theapplication may generate one or more access plans and associate theaccess plan(s) with the patient images, e.g., by displaying the accessroute(s) over the patient images. Additionally or alternatively, theapplication may allow the physician to identify and/or draw one or moreaccess plans on the patient images. The application may be available tothe physician in advance of the procedure (e.g., for planning a route ofaccess based on the location/characteristics of a stone), during theprocedure (e.g., for comparing to real-time imaging to confirm apre-determined access route and location/characteristics of the stone),and/or after the procedure (e.g., for further post-operative analysis ofthe access route taken during the procedure).

FIG. 2 shows a schematic diagram of an exemplary computer system andenvironment for collecting, processing, and displaying patient-specificdata according to an exemplary embodiment of the present disclosure. Thecomputer system 200 may include one or more user devices 202 foraccessing and/or manipulating data and one or more servers, e.g.,servers 206A, 206B, 206C, 206D (each of which may have a correspondingdatabase 207A, 207B, 207C, 207D), in communication with an electroniccommunication network 205. The network 205 may include the Internet, avirtual private network, or any other combination of wired and/orwireless electronic communication networks. The system 200 also mayinclude one or more imaging devices 204 for obtaining and accessingmedical images of a patient.

Each user device 202 may be a stationary or mobile electronic device,including electronic computing devices. Non-limiting examples of suchelectronic devices include laptop computers, desktop computers, tabletcomputers (including, e.g., Apple iPad, Samsung Galaxy, Amazon Kindle,and Microsoft Surface devices), smartphones, digital cameras.Non-limiting examples of imaging devices 204 include CT scanners,stationary fluoroscopy machines, mobile C-arm devices, and otherangiographic/radiographic devices, as well as cameras, ultrasound(transducer) devices, and magnetic resonance imaging (MRI) machines.

Each user device 202 may include a processor, memory, a display, one ormore user input devices, and a network communication interface. The userinput device may be, e.g., a display monitor, touchpad, touchscreen,keyboard, or mouse, among other types of devices and device featuresproviding for user input/output capability. The user device(s) 202 mayinclude a display or graphical user interface for receiving user inputand displaying data through an application program (“app”). Exemplaryscreenshots of a user device in the form of a tablet computer 500 areshown in FIGS. 5 and 6, discussed below. The user device(s) 202 mayimplement appropriate security protocols, such as requiring the user toenter logon credentials to limit access to patient data and comply withapplicable health regulations, such as the Health Insurance Portabilityand Accountability Act (HIPAA).

Each user device 202 and imaging device 204 may be configured to sendand/or receive data, including patient data, over the network 205. Thepatient data obtained and/or accessed over the network 205 may include,but is not limited to, any imaged, detected, measured, processed, and/orcalculated physiological data including, e.g., data for various featuresof the urinary, musculoskeletal, gastrointestinal, dermatological,respiratory, or vascular systems. For example, the patient data mayinclude one or more images of the left and/or right kidneys andsurrounding anatomy, such as the left and/or right ureters, renalarteries, renal veins, pelvis, spine, adrenal glands, bladder, and/orurethra. Each image may be associated with the time, date, location,and/or instrument with which the image was taken. In some embodiments,the patient data may include biographical information (e.g., patientname, age, gender, etc.) and/or other physiological health parameters(e.g., average heart rate, body temperature, etc.).

Various medical imaging techniques may be used to collect patient data.For example, images may be generated by a CT scanner and/or byrotational angiography. CT scans generally provide a series ofcross-sectional images or “slices” taken at different angles while thepatient is immobile, wherein the slices may be assembled into athree-dimensional (3D) image. Rotational angiography may be performedduring surgery, e.g., by a mobile C-arm, or while a patient is immobile,but are generally of lower quality than CT scans. For some imagingprocedures, a contrast agent may be used to assist in identifyinganatomical features in the images. For example, a contrast agent may beintroduced into the patient (e.g., via the patient's urinary tract viathe ureter) prior to imaging to assist in visualization of the kidneysand urinary system.

FIG. 3 illustrates an exemplary mobile C-arm device 300 useful forcollecting X-ray images of a patient 350 in preparation for and/orduring a PCNL procedure, according to some aspects of the presentdisclosure. As shown, the “C-arm” 305 of the imaging device 300 includesan X-ray tube 308 aligned with a detector 310 positioned on the oppositeside of the patient 350. The C-arm 305 may be rotatable relative to thepatient in one or more planes (e.g., about an axis parallel and/or anaxis perpendicular to the patient 350) to allow for the collection ofimages in different orientations, without moving the patient 350. Theimages may be displayed and analyzed in real time on a monitor ordisplay 316 of the imaging device 300 and/or may be stored locally orremotely for later viewing and analysis. For example, the C-arm device300 may be used to collect patient images during a PCNL procedure, e.g.,wherein the physician may consult the images for guidance on properpositioning of the insertion needle, nephroscope, and other instrumentsduring the procedure.

The mobile C-arm device 300 may include a light source to identify aspecific target or region of a patient, such as an intended incision orinsertion site. For example, the C-arm 305 may include a light sourcecoupled to or incorporated into the X-ray tube 308, wherein the lightsource may be used to direct light on a pre-determined insertion sitefor a PCNL procedure. FIG. 3 illustrates light 311 focused on the backof the patient 350 in the form of an “X” or crosshairs to indicate theintended site of insertion. The direction, orientation, intensity,and/or shape of the light generated by the light source may becontrolled via user input at the display 316 and/or by instructionsreceived over the network 205, as discussed further below.

Returning to FIG. 2, the servers 206A-206D may be configured to receivepatient data over the network 205, e.g., from user devices 202, imagingdevices 204, other servers, and/or a shared cloud network. Each server206A-206D may perform different functions, or certain functions may beshared by two or more servers 206A-206D. Each server 206A-206D mayinclude a processor and memory for executing and storingprocessor-readable instructions. One or more of the servers 206A-206Dmay be communicatively coupled to a corresponding database 207A-207Dconfigured to store data (e.g., patient data) accessible to the server206A-206D. At least one server 206A-206D may include a data analyzerconfigured to perform analysis of received data and/or an applicationprogram that allows a physician to control analysis parameters, such asthreshold values used by the data analyzer in performing the analyses.

In some embodiments, the system 200 may include an imaging server 206A,a patient records server 206B, a reference data server 206C, and anapplication server 206D. As mentioned above, more or fewer servers maybe used. For example, in some embodiments, the functions performed byimaging server 206A, patient records server 206B, reference data server206C, and application server 206D (or any combination thereof) may beimplemented by a single server.

The imaging server 206A may receive, process, and/or transmit patientimages for viewing and analysis according to the methods herein. Forexample, the imaging server 206A may receive images generated by theimaging device(s) 204, perform one or more processing steps, andtransmit the processed images for viewing on the user device(s) 202.Additionally or alternatively, the imaging server 206A may retrieveimages saved to the database 207A, which may correspond to prior imagesobtained for the patient. Image processing steps may include, but arenot limited to, assembling multiple images into a 3D representation ormodel, associating images with patient information, grouping togetherimages of similar type and/or date, reducing noise, and/orrecognizing/labeling particular anatomical features. Image processingmay be performed by appropriate algorithms known generally in the art.In some embodiments, multiple images generated by the same or differentdevices may be layered (e.g., one image overlaying another) and/orcombined into a single two- or three-dimensional image.

The patient records server 206B may be used to retrieve patent-specificinformation for associating with the images and/or viewing on the userdevice(s) 202. For example, the patient records server 206B maycorrespond to a server of the hospital or medical office where thepatient has previously received or routinely receives medical treatment.Information received and/or transmitted by the patient records server206B may include, but is not limited to, the patient's name, date ofbirth, age, contact information, general medical condition, priorsurgeries and other medical events (including prior kidney stoneincidence), physiological information (e.g., average blood pressure,average heart rate, etc.), and other patient-specific information thatmay be helpful to a physician in planning a PCNL procedure or othermedical procedure. In some embodiments, the patient records server 206Bmay retrieve patient information from records stored in database 207B.

The reference data server 206C may be used to access relevant data frommedical case studies for reference and/or comparison to the patientdata. For example, aggregated data from medical case studies may be usedto automatically identify different features in the patient images(e.g., the renal capsule, the major/minor calyces, and renal pelvis ofthe kidney, and/or possible location of a kidney stone). In someembodiments, the reference data server 206C may compare the patient datato various case study data (e.g., the case study records optionallysaved in database 207C) to attempt to locate one or more referencepatient profiles. For example, the reference patient profile(s) mayinclude information on the removal of kidney stones of similar sizeand/or location as that of the patient.

The application server 206D may communicate with the user device(s) 202to transmit and/or receive instructions for generating and displayingpatient data tailored to the user's preferences and needs. Theapplication server 206D may assemble the patient data, e.g., from otherservers 206A-206C, imaging device(s) 204, and perform analyses,calculations, and/or generate simulations as needed. For example theapplication server 206D may send instructions to the user device(s) 202to prompt the user for input, and may process data received from one ormore other servers 206A-206C (or information saved in database 206D)based on the user input to modify the information displayed on the userdevice(s) 202 accordingly.

FIG. 4 shows a flow diagram of an exemplary method 400 for collecting,processing, and displaying patient data, using the system of FIG. 2.Method 400 may include receiving patient images (step 401), such as froman imaging device 204 and/or the imaging server 206A discussed above.The received patient images then may be processed (step 403), e.g., viathe imaging server 206A and/or application server 206D. Step 403 mayinclude any of the processing/modification techniques discussed above.In some embodiments, for example, step 403 may include generating a 3Drepresentation of the kidney and surrounding anatomy from received CTscans, automatically identifying different features of the kidney and/orsurrounding tissues, and/or automatically identifying one or more accessplans for removing a kidney stone.

The processed/modified images then may be displayed on one or more userdevices 202 (step 405), such as a tablet computer. Next, a request foruser input may be generated (step 407), e.g., as a prompt on the screenof the tablet computer. For example, the screen may show a text boxasking the user to identify and/or confirm specific structures of thekidney and the location of any kidney stones, e.g., by touching thescreen. In some embodiments, the user may be prompted to draw an accessplan and/or highlight one or more portions of an access plan, e.g., bydragging a digit (finger or thumb), or a stylus across the screen.

In some embodiments, the user input may include a request to furtherprocess/modify the patient images (step 409). For example, the userdevice 202 may receive a user request to calculate the dimensions and/ordensity of a stone that the user has marked, or to generate a new 3Dmodel of the kidney based on a different selection of images, adifferent algorithm, or other parameters. Thus, the method may includerepeating step 403 one or more times. In some embodiments,processing/modifying the patient images may include accessing patientrecords (step 411) and/or accessing reference data (step 413), such ascase study information as discussed above. The processed images againmay be displayed on the user device(s) 202 (step 405).

In some embodiments, the user input may not require further processingof the images. For example, the user may wish to manipulate the imagesthat have already been processed and displayed on the user device(s)202, e.g., to magnify, miniaturize, and/or rotate an image or portionsof an image, to browse through a series of images (e.g., individualslices from a CT scan), and/or to change the layout of multiple imagesas displayed on the user device(s) 202. Upon receiving user input tomodify the display (step 415), the user device 202 may perform thecorresponding function to perform the modification (step 417).

Each user device 202 may have an appropriate interface or controls toallow the user to select different options for manipulating patientimages. For example, the user may select from menu options via akeyboard or mouse, or via a touchscreen. For user devices 202 with atouchscreen, such as some smartphone and tablet computers, the userdevice 202 may be configured to associate the type of user input with aparticular function. For example, the user device 202 may be configuredto determine when the user's fingers pinch the surface of thetouchscreen. If the user's fingers move closer together, the user device202 may zoom out from the displayed images, whereas if the user'sfingers move away from each other, the user device 202 may zoom in onthe images being displayed. The amount of the zoom may depend on thedistance that the finger(s) travel in the pinch along the surface of thetouchscreen.

The user device(s) 202 may communicate with one or more of the servers206A-206D over the network 205 as discussed above to transmit data suchas user instructions and/or receive data such as patient images(including any processed images) and other patient data, reference data,or instructions to generate a prompt requesting user input. In someembodiments, the user device(s) 202 may be configured to perform some orall image processing or other data processing functions.

FIGS. 5 and 6 illustrate exemplary user interfaces of a tablet computer500 as an exemplary user device 202 according to some embodiments of thepresent disclosure. The tablet computer 500 may have a touchscreenconfigured to receive input from the user based on contact by at leastone of the user's digits (e.g., one or more fingers or thumbs) on asurface of the touchscreen. It is understood that the touchscreen may beconfigured to receive input from the user based on contact or sensedproximity to the touchscreen by the user's finger(s), the user'sthumb(s), a stylus, another pointing object or instrument, or acombination thereof. Further, it is understood that user devices 202according to the present disclosure need not have a touchscreen, but mayreceive user input through other input devices known in the art,including the user input devices mentioned above.

The tablet computer 500 may include a display 501 for displayinginformation and a user element 503, which may allow the user to exit theapplication and/or power on/off the tablet computer 500. The display 501may show one image or multiple images, e.g., separated into differentpanels. For example, FIG. 5 shows the display 501 divided into fourpanels 502A, 502B, 502C, and 502D, and FIG. 6 shows the display 501divided into three panels 522A, 522B, and 522C. The panels may have thesame or substantially the same size and shape, as in FIG. 5, or may havedifferent shapes and/or different dimensions relative to the otherpanels, as shown in FIG. 6. Different types of images may be shown inthe various panels, e.g., to highlight various anatomical structures andfeatures. The panels may show raw data (e.g., raw images collected viaCT scan, X-ray, fluoroscopy, or rotational angiography),manipulated/processed data (including, but not limited to, simplifiedimages or access plans/representations, annotated images, layered imagedata), simulated data (including, but not limited to, 3D simulations,access plans/representations with simulated access routes, and raw orprocessed images with simulated features). The panels may includeannotations generated by the system or provided by user input toidentify features and/or provide information or various metrics forreference. For example, the panels may show density information, stoneburden, and/or skin-to-stone distance, among other metrics.

For example, the different panels may show one or more X-ray images, oneor more CT images, which may be collected at different angles providingfor planar views in various x, y, z coordinates (e.g., coronal,sagittal, and transverse views), and/or one or more fluoroscopic images.These different views may assist a user in determining the positionand/or size of kidney stones. For example, the user may use thedifferent views to mark various features of the kidney, so that multipleCT image views may be combined to visualize the structure of the kidneyin three dimensions. FIG. 5 shows a transverse CT image in panel 502B, asagittal CT image in panel 502C, a coronal CT image in panel 502D, and akidney-ureter-bladder X-ray in panel 502A. FIG. 6 shows a transverse CTimage in panel 522A (which may be the same image shown in panel 502B ofFIG. 5), a coronal CT image in panel 522B (which may be the same imageshown in panel 502D of FIG. 5), and a 3D image in panel 522Creconstructed from CT data, showing a kidney, its calyces, and a kidneystone. The user may be able to manipulate the 3D image, such as byrotating the image and/or zooming in or out on particular features orregions of interest. For example, the user may manipulate the 3D imageto view different angles of needle insertion by rotating the imageand/or zooming in or out on particular features.

The display 501 may include a menu 510 with one or more menu options(icons 510A-510F, as shown) to allow the user to select among differentoptions for displaying and/or processing the images. For example, afirst menu option 510A may be selected to identify and/or characterizedifferent anatomical structures or features shown. An exemplary list ofitems is shown in FIG. 5, including the kidney capsule, calyces of thekidney, the kidney stone burden (the size of the stone), and/or thelocation of any reference markers. The list may include a progressindicator for each item showing whether additional user input is desiredor required. The user may select identify different features using thetouchscreen, wherein the user device 202 and/or other components of thesystem 200 may use image recognition algorithms to identify/outline theentire structure (e.g., by detecting surrounding areas of the samecontrast level).

A second menu option 510B may allow a user to view data corresponding toa particular feature, such as a kidney stone. FIG. 6 shows a list ofdata corresponding to a kidney stone 575 shown in the image of panel522C. The data may be calculated by the system 200, or may be alreadyassociated with the patient images. As shown, the data may include thestone burden (e.g., the dimensions of the stone, in mm), the stonedensity (radiodensity calculated by CT scan, according to the Hounsfieldscale), the distances from the patient skin surface to kidney capsule,calyx, and stone 575, and the projected angle for inserting the needleduring a PCNL procedure to reach the stone.

A third menu option 510C may allow a user to change various settings,such as sensitivity settings, different algorithms to be used, a defaultof how many image panels to be shown at initiation of the application,etc. A fourth menu option 510D may indicate information aboutconnectivity to the network 205, a fifth menu option 510E may allow auser to print information such as a surgical template as discussedbelow, and a sixth menu option 510F may allow a user to upload and/ordownload patient images or other patient data or information over thenetwork 205. Menu options 510A-510F are intended to be exemplary; themenu 510 may include other types of menu options, and fewer or more menuoptions than shown.

In some embodiments, portions of the display 501 may show text and/orannotation to the images shown. For example, the text may includeinformation about the patient, information about the images shown on thedisplay 501, or comments from a physician or other medical professional,among other types of information. Further, for example, the annotationmay identify various anatomical features or reference markers, or mayreflect information about an access plan or projected needle trajectory.Each of FIGS. 5 and 6 show a text box 505 overlaying a portion of thedisplay 501 with information about the patient (patient name) and theimages shown (the date the images were obtained). FIG. 6 further showsannotation to the images shown in each of panels 522A, 522B, and 522C toindicate a needle insertion depth of 8.02 cm (skin to stone) at an angleof 30 degrees.

As mentioned above, the system 200 may allow a physician or other userto identify and evaluate different access plans. The system 200 mayidentify one or more access plans automatically (e.g., during theprocessing of images, step 403 of method 400) and/or may highlightvarious access plans upon user input. For example, the user may selectdifferent images and/or rotate a 3D representation of the kidney toassess different pathways to reach the stone, and may draw or highlighta chosen access plan by dragging a digit (finger or thumb) or stylusacross the screen. Upon detecting the dragging motion, the user device202 and/or other components of the system 200 may use image recognitionalgorithms to identify/outline the entire pathway, e.g., identifyingeach access plan in a different color. A user may choose a desiredaccess plan, whereupon the user device 202 and/or other components ofthe system 200 may generate a “final” access plan including thelocation, depth, and trajectory angle(s) with respect to the skinsurface at which the needle should be inserted to reach the kidney andstone with minimal injury to the patient.

In some embodiments, the user device 202 may allow the user to generateand print a patient template to assist in performing a PCNL procedure.FIGS. 7A and 7B illustrate a patient template 700 according to someaspects of the present disclosure. For example, the patient template 700may include one or more markings 705 to indicate the location forinserting the needle 730, and one or more markings 707 to indicate thetrajectory of the needle 730, according to the access plan generated bythe system 200. For example, a first marking 705 (e.g., an X) mayidentify the location for inserting the needle 730, and a second marking707 leading away from the first marking 705 (e.g., a line) may identifythe trajectory for the needle 730 to follow once inserted. For example,the system 200 may generate an access plan having an angle of 30 degrees(see FIGS. 5 and 6), which may correspond to the angle the needle shouldmake with the patient 750 when aligned with the second marking 707 andinserted at the first marking 705. In some embodiments, the trajectoryangle(s) of the needle 730 may be printed on the patient template 700.In some embodiments, the insertion site for the needle 730 also may beindicated by a light source of an imaging device (e.g., a light sourcecoupled to or incorporated into the X-ray tube 308 of a mobile C-armdevice 300, as shown in FIG. 3) to be used during the PCNL procedure.

The patient template 700 may include one or more additional markings toprovide references for placing the patient template 700 in the correctlocation on the patient 750. FIG. 7A shows two reference markings 715,represented in this example as curved lines, to assist in placement ofthe patient template 700 relative to anatomical features, such as thepatient's ribs or vertebrae, the location of which may be derived fromCT data and palpated pre-operatively. The patient template 700 may bepositioned on the patient such that the reference markings 715 matchtheir respective anatomical features to serve as landmarks for correctorientation of the patient template 700.

Additionally or alternatively, the patient template 700 may includereference markings 713 to be aligned with corresponding referencemarkers (e.g., radiopaque fiducials) placed externally on the patient'sskin. For example, one or more reference markers placed at discretelocations on the patient may be visible during imaging, and provideadditional triangulation information for proper insertion of the needle730.

The types and locations of any reference markings 713, 715 of thepatient template 700 may be automatically generated by the user device202 and/or other components of the system 200, or may be added by userinput to the user device 202. Further, the patient template 700 mayinclude other information as desired, e.g., to confirm that the patienttemplate 700 is being used with the correct patient 750.

The patient template 700 may be printed on a sheet of porous material,e.g., gauze or polymeric mesh fabric, for transferring the template tothe patient 750. The material of the printed patient template 700 may benon-sterile. As shown in FIG. 7B, the various markings 705, 707, 713,715 then may be traced and transferred to the patient 750. The markings705, 707, 713, 715 may remain visible after the patient 750 is scrubbedto render the surgical environment sterile for the PCNL procedure.

Other embodiments of the present disclosure will be apparent to thoseskilled in the art from consideration of the specification and practiceof the embodiments disclosed herein. While certain features of thepresent disclosure are discussed within the context of exemplarysystems, devices, and methods, the disclosure is not so limited andincludes alternatives and variations of the examples herein according tothe general principles disclosed. It is intended that the specificationand examples be considered as exemplary only, with a true scope andspirit of the present disclosure being indicated by the followingclaims.

We claim:
 1. A method for determining a patient-specific surgical accessplan for a medical procedure using at least one computer system, themethod comprising: receiving over an electronic network, at the at leastone computer system, a plurality of radiographic images of an anatomicalstructure of a patient; generating a first three-dimensional image on adisplay, using a processor, representing the anatomical structure byoverlaying the plurality of radiographic images, wherein the processorautomatically identifies an object in the first three-dimensional imageas a kidney stone; generating, on the display, a prompt requesting userinput to identify features of the anatomical structure in the firstthree-dimensional image and to identify at least a portion of an accessplan for performing the medical procedure; responsive to the prompt,receiving a first user input identifying the features of the anatomicalstructure, wherein the first user input includes one or more touchinputs on the display; responsive to the prompt, receiving a second userinput identifying at least the portion of the access plan for performingthe medical procedure, wherein the second user input includes a draggingmotion on the display; receiving a third user input on the display, thethird user input including an instruction to generate a secondthree-dimensional image on the display, the second three-dimensionalimage being different from the first three-dimensional image; generatingthe second three-dimensional image on the display, using a processor,the second three-dimensional image including the features of theanatomical structure selected by the first user input; identifying, bythe processor, at least one access plan for performing the medicalprocedure based at least on the first user input and the second userinput, wherein the at least one access plan includes the portion of theaccess plan identified by the user; and generating a display of theidentified at least one access plan associated with the secondthree-dimensional image, wherein the prompt requesting user inputincludes a text box asking a user to confirm that the object in theplurality of radiographic images is the kidney stone.
 2. The method ofclaim 1, wherein the medical procedure is percutaneous nephrolithotomyor percutaneous nephrolithotripsy, and the anatomical structure is akidney.
 3. The method of claim 1, wherein the plurality of radiographicimages includes images obtained by computer tomography.
 4. The method ofclaim 1, further comprising automatically identifying one or morefeatures of the anatomical structure in the first three-dimensionalimage before generating the at least one request for user input.
 5. Themethod of claim 1, further comprising modifying the firstthree-dimensional image based on the first user input.
 6. The method ofclaim 5, wherein modifying the first three-dimensional image includescomparing the plurality of radiographic images to reference patient datafor the medical procedure.
 7. The method of claim 1, further comprisinggenerating a patient template that indicates an insertion site accordingto the identified at least one access plan.
 8. The method of claim 7,wherein generating the patient template includes printing one or moremarkings identifying the insertion site to a sheet for transfer to apatient.
 9. A method for determining a patient-specific surgical accessplan for a medical procedure using at least one computer system, themethod comprising: receiving over an electronic network, at the at leastone computer system, one or more radiographic images of an anatomicalstructure of a patient; generating a display of the one or moreradiographic images; identifying one or more objects in the one or moreradiographic images as a kidney stone by comparing the one or moreradiographic images to reference patient data: calculating, by the atleast one computer system, at least a stone burden and a stone densityof the kidney stone based on the one or more radiographic images;generating, on the display, at least one request for user input toidentify features of the anatomical structure in the one or moreradiographic images and to identify at least a portion of an access planfor performing the medical procedure; receiving a first user inputidentifying the features of the anatomical structure, wherein the firstuser input includes one or more touch inputs on the display; receiving asecond user input identifying an initial portion of the access plan forperforming the medical procedure, wherein the second user input includesa dragging motion on the display; automatically identifying, using oneor more image recognition processes, a remaining portion of the accessplan for performing the medical procedure based on the initial portionof the access plan, wherein one or more of the initial portion and theremaining portion of the access plan are identified based, at least inpart, on the stone burden and the stone density of the kidney stone;receiving a third user input on the display, the third user inputincluding an instruction to generate a three-dimensional image on thedisplay, the three-dimensional image including at least one radiographicimage from the one or more radiographic images; generating thethree-dimensional image on the display, using a processor, thethree-dimensional image including the features of the anatomicalstructure identified by the first user input; generating a display ofthe access plan over the three-dimensional image; and performing themedical procedure by inserting a needle into the patient at an insertionsite according to the access plan, wherein the insertion site isidentified by a light source in communication with the electronicnetwork, wherein the medical procedure is percutaneous nephrolithotomyor percutaneous nephrolithotripsy, and the anatomical structure is akidney.
 10. The method of claim 9, wherein generating the at least onerequest for user input includes asking a user to identify or confirm alocation of the kidney stone identified in the one or more radiographicimages.
 11. The method of claim 10, further comprising calculating atleast one characteristic of the kidney stone based on a skin to a kidneycapsule distance or the skin to the kidney stone distance.
 12. Themethod of claim 11, further comprising calculating a needle trajectorybased on the calculated at least one characteristic of the kidney stone,wherein the access plan is further based, at least in part, on theneedle trajectory.
 13. The method of claim 9, wherein the access planincludes a location and a depth for inserting a needle at an insertionsite.
 14. The method of claim 13, wherein the access plan includesinformation on a trajectory of the needle for insertion.
 15. The methodof claim 9, wherein the light source includes an “X” or crosshairs toidentify the insertion site.
 16. A method for determining apatient-specific surgical access plan for a medical procedure using atleast one computer system, the method comprising: receiving over anelectronic network, at the at least one computer system, a plurality ofradiographic images of an anatomical structure of a patient; generatinga first three-dimensional image on a display, using a processor,representing the anatomical structure by overlaying the plurality ofradiographic images; identifying one or more objects as a kidney stoneby comparing the first three-dimensional image to reference patientdata; generating, on the display, at least one request for user input toidentify features of the anatomical structure in the firstthree-dimensional image and to identify at least a portion of an accessplan for performing the medical procedure; receiving a first user inputidentifying the features of the anatomical structure, wherein the firstuser input includes one or more touch inputs on the display; receiving asecond user input identifying an initial portion of the access plan forperforming the medical procedure, wherein the second user input includesa dragging motion on the display; automatically identifying, using oneor more image recognition processes, a plurality of access plans forperforming the medical procedure based on the initial portion, each ofthe plurality of access plans including the initial portion and adifferent option for a remaining portion of the access plan; receiving athird user input on the display, the third user input including aninstruction to generate a second three-dimensional image on the display,the second three-dimensional image being different from the firstthree-dimensional image; generating the second three-dimensional imageon the display, using a processor, the second three-dimensional imageincluding the features of the anatomical structure selected by the firstuser input; generating a display of the plurality of access plans oversecond three-dimensional image; receiving a fourth user input on thedisplay, the fourth user input including a selection of one of theplurality of access plans; and generating a patient template thatindicates an insertion site for the medical procedure according to theselected access plan; wherein the medical procedure is percutaneousnephrolithotomy or percutaneous nephrolithotripsy, and the anatomicalstructure is a kidney, and wherein generating the patient templateincludes printing at least a first marking and a second marking to asheet for transfer to a patient, the first marking identifying theinsertion site according to the selected access plan and the secondmarking providing a reference relative to an anatomical feature of thepatient.
 17. The method of claim 16, wherein generating the at least onerequest for user input includes asking a user to confirm a location ofthe kidney stone in the first three-dimensional image.
 18. The method ofclaim 17, further comprising calculating, by the processor, at least onecharacteristic of the kidney stone chosen from stone burden, stonedensity, a skin to a kidney capsule distance, the skin to the kidneystone distance, or a combination thereof.
 19. The method of claim 1,wherein the method further comprises calculating, by the processor, atleast one characteristic of the kidney stone based on the firstthree-dimensional image, wherein the at least one characteristic ischosen from stone burden or stone density, and wherein identifying theat least one access plan includes calculating a needle trajectory basedon the calculated at least one characteristic of the kidney stone. 20.The method of claim 18, further comprising calculating a needletrajectory based on the calculated at least one characteristic of thekidney stone, wherein the plurality of access plans are further based,at least in part, on the needle trajectory.